Sources
[1] The SpectraWAVE HyperVue Imaging System and the Starlight Imaging Catheter is a US Class 2 device cleared by FDA through K221257 and K230691. The SpectraWAVE X1-FFR Software is a US Class 2 device cleared by FDA through K251355.
[2] Compared with angiography-guided Percutaneous Coronary Interventions.
[3] AI-derived algorithms are deployed on the device to support vessel segmentation and contouring. Analytical (non-AI) models are used for generating FFR values.
[4] Stark, B., Johnson, C., & Roth, G. A. (2024). Global prevalence of coronary artery disease: An update from the Global Burden of Disease Study. Journal of the American College of Cardiology, 83(13 Suppl), 2320. https://doi.org/10.1016/S0735-1097(24)04310-9
[5] Mandurino-Mirizzi, A., Munafò, A. R., Rizzo, F., De Francesco, R., Raone, L., Germinal, F., Montalto, C., Mussardo, M., Moci, M., Vergallo, R., Rocco, V., Fischetti, D., Dionigi, F., Godino, C., Colonna, G., Oreglia, J., Burzotta, F., Crimi, G., & Porto, I. (2025). Comparison of different guidance strategies to percutaneous coronary intervention: A network meta-analysis of randomized clinical trials. International Journal of Cardiology, 422, 132936. https://doi.org/10.1016/j.ijcard.2024.132936
[6] Stone, G. W., Christiansen, E. H., Ali, Z. A., Andreasen, L. N., Maehara, A., Ahmad, Y., Landmesser, U., & Holm, N. R. (2024). Intravascular imaging-guided coronary drug-eluting stent implantation: An updated network meta-analysis. The Lancet, 403(10429), 824–837. https://doi.org/10.1016/S0140-6736(23)02454-6
[7] Gaster, A. L., Slothuus Skjoldborg, U., Larsen, J., Korsholm, L., von Birgelen, C., Jensen, S., Thayssen, P., Pedersen, K. E., & Haghfelt, T. H. (2003). Continued improvement of clinical outcome and cost effectiveness following intravascular ultrasound guided PCI: Insights from a prospective, randomized study. Heart, 89(9), 1043–1049. https://doi.org/10.1136/heart.89.9.1043
